PROTOCOL REVIEW AND MONITORING SYSTEM: PROJECT SUMMARY/ABSTRACT Cancer clinical trials are a necessary and integral part of the research activities at the Virginia Commonwealth University (VCU) Massey Cancer Center (MCC) as they provide the opportunity for cancer patients to receive the most promising new therapies and provide the mechanism that brings MCC laboratory findings into the clinic. The MCC clinical trials program has 3 major goals: (1) to facilitate investigator-initiated and other clinical research trials; (2) to provide an appropriate menu of clinical trials to address the cancer burden of patients within MCC?s catchment area; and (3) to advance cancer care through research. The broad, long-range objectives of the Protocol Review and Monitoring System (PRMS), operationalized through the Protocol Review and Monitoring Committee (PRMC), are to ensure that the clinical research portfolio consists of meaningful and scientifically sound studies and that these studies are conducted appropriately in terms of patient accrual, data analysis, and patient safety. Due to the importance of cancer clinical trials, the resources required to conduct clinical trials, and the value placed on human subjects who enroll on the studies, all proposed cancer clinical and population science protocols at VCU undergo an internal review of the scientific merit and prioritization before their submission to the Institutional Review Board. Prioritization of trials is necessary to facilitate progress of the most important science and optimize the use of MCC research resources. The PRMC conducts an initial and on-going review of all cancer clinical trials for scientific merit and scientific progress. The PRMC establishes priorities among trials potentially competing for MCC resources or patients. On-going review consists of review of amendments, accrual, and reports of the Data and Safety Monitoring Committee that identify potentially serious concerns. Trials are closed in the case of inadequate accrual, a change in priorities, or problems with clinical trial conduct that are so serious as to render the results of the clinical trial meaningless. These objectives are relevant to the mission of the National Cancer Institute as they advance the agency?s goals of preventing, controlling, and treating cancer.